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pregabalin

Trade name: lyrica

Small moleculeapproved

Approved

Dec 30, 2004

Pregabalin, marketed under the brand name Lyrica among others. LYRICA is indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) Postherpetic neuralgia (PHN); Adjunctive therapy for adult patients with partial onset seizures; Fibromyalgia; Neuropathic pain associated with spinal cord injury. It has been shown the clinical effects of pregabalin are likely due to direct and selective interactions with α(2)δ-1 and α(2)δ-2 subunits of voltage-gated calcium channels. While pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid (GABA), it does not bind directly to GABAA, GABAB, or benzodiazepine receptors, does not augment GABAA responses in cultured neurons, does not alter rat brain GABA concentration or have acute effects on GABA uptake or degradation. However, in cultured neurons prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport. Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake. — NCATS

Clinical trial activity

531 trials · 345 clinical orgs · 53 marketing orgs

Phase 1
63
Phase 2
205
Phase 3
145
Phase 4
138

Earliest trial started Nov 1, 1997 (NCT00141414)

Timeline

1990s

  1. Jan 1, 1997

    Pfizer — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1998

    Pfizer — Earliest Phase 3 Sponsor(trial)

2000s

  1. Dec 30, 2004

    Pfizer — Earliest FDA Approval

  2. Dec 30, 2004

    Cp Pharma — NDA Secondary Org

  3. Dec 30, 2004

    Pfizer — NDA Organization

  4. Dec 30, 2004

    Pfizer — Marketing Organization

  5. Dec 30, 2004

    Upjohn — Marketing Organization

  6. Dec 30, 2004

    Wockhardt — NDA Secondary Org

  7. Jan 1, 2007

    Pfizer — Earliest Phase 1 Sponsor(trial)

2010s

  1. Sep 26, 2012

    Wockhardt — Marketing Organization

  2. Sep 26, 2012

    Healthcare Pharma Ltd — Marketing Organization

  3. Dec 31, 2012

    Sandoz — Marketing Organization

  4. Dec 31, 2012

    Novartis — Marketing Organization

  5. Jun 4, 2013

    Lupin — Marketing Organization

  6. Jan 10, 2014

    Actavis — Marketing Organization

  7. Feb 21, 2014

    Apotex — Marketing Organization

  8. Oct 23, 2014

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  9. Apr 27, 2015

    Teva — Marketing Organization

  10. Apr 27, 2015

    Watson Pharmaceuticals — Marketing Organization

  11. Apr 27, 2015

    Allergan PLC (2015) — Marketing Organization

  12. May 18, 2016

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  13. May 18, 2016

    Neogen — Marketing Organization

  14. Dec 7, 2017

    Prinston Inc — Marketing Organization

  15. Nov 23, 2018

    Sciegen Pharmaceticals — Marketing Organization

  16. Dec 14, 2018

    Invagen Pharms — Marketing Organization

  17. Dec 21, 2018

    Alembic — Marketing Organization

  18. Dec 27, 2018

    Aurobindo Pharma — Marketing Organization

  19. Dec 27, 2018

    Cadila Healthcare — Marketing Organization

  20. Jan 4, 2019

    Torrent Pharmaceuticals Limited — Marketing Organization

  21. Jan 9, 2019

    MSN Laboratories — Marketing Organization

  22. Jan 29, 2019

    Alkem Labs Ltd — Marketing Organization

  23. Jul 19, 2019

    Amneal Pharmaceuticals — Marketing Organization

  24. Jul 19, 2019

    Dr. Reddy's Laboratories — Marketing Organization

  25. Jul 19, 2019

    Rising Pharmaceuticals — Marketing Organization

  26. Sep 20, 2019

    Mylan — Marketing Organization

  27. Sep 30, 2019

    Hainan GeneralSanyang Pharmaceutical Co.,Ltd — Marketing Organization

  28. Sep 30, 2019

    Shuangcheng — Marketing Organization

  29. Sep 30, 2019

    Yiling Pharmaceutical Inc. — Marketing Organization

  30. Oct 8, 2019

    Hetero Labs Ltd — Marketing Organization

  31. Nov 29, 2019

    Sun Pharmaceuticals — Marketing Organization

  32. Dec 26, 2019

    Shijiazhuang Pharma Group (CSPC) — Marketing Organization

  33. Dec 26, 2019

    Renata — Marketing Organization

2020s

  1. Jan 10, 2020

    Cipla — Marketing Organization

  2. Mar 20, 2020

    Celltrion — Marketing Organization

  3. Mar 20, 2020

    Chartwell Pharmaceuticals — Marketing Organization

  4. Mar 23, 2020

    Hikal — Marketing Organization

  5. Mar 23, 2020

    CREEKWOOD PHARMS — Marketing Organization

  6. Jul 9, 2020

    AbbVie — Marketing Organization

  7. Apr 13, 2021

    Alvogen — Marketing Organization

  8. Jul 15, 2021

    Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd. — Marketing Organization

  9. Feb 18, 2022

    Patrin Pharma Inc — Marketing Organization

  10. Mar 8, 2022

    ESKAYEF — Marketing Organization

  11. Mar 22, 2022

    Rubicon Research — Marketing Organization

  12. Jul 18, 2022

    Marksans Pharma — Marketing Organization

  13. Jul 18, 2022

    Adaptis Pharma — Marketing Organization

  14. Aug 26, 2022

    Zydus Discovery DMCC — Marketing Organization

  15. Apr 26, 2023

    ACI Limited — Marketing Organization

  16. Jun 1, 2023

    Sinotherapeutics — Marketing Organization

  17. Jun 1, 2023

    Epic Pharma Llc — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewDec 30, 2004

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)C[C@H](CN)CC(O)=O
Mol. weight
159.2261 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 3-isobutyl gaba
  • 3-isobutyl gaba
  • alzain
  • axalid
  • bms-954561
  • ci-1008
  • ci-1008
  • gabanext
  • kw21052
  • lecaent
  • lyrica
  • lyrica
  • lyrica
  • lyrica
  • lyrica
  • maxgalin
  • pd-144723
  • pd-144723
  • pregabalin
  • pregabalin
  • pregabalin
  • pregabalin
  • pregabalin
  • pregabalin
  • pregabalin
  • pregabalin
  • pregabalin
  • pregabalin
  • pregabalin
  • pregabalin
  • pregabalin hcl
  • pregabalin hydrochloride
  • pregaballine
  • rewisca
  • (s)-3-isobutyl gaba
  • (s)-3-isobutyl gaba
  • s-(+)-3-isobutylgaba
  • s-(+)-3-isobutylgaba
  • (s)-pregabalin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07288528Phase 4Apr 1, 2026McMaster University
NCT07275762Phase 2Jan 1, 2026NeuroDawn Pharmaceutical Co., Ltd.
NCT06715462Phase 3Nov 30, 2025Eurofarma Laboratorios S.A.
NCT07208357N/AOct 20, 2025Capital Medical University
NCT07206680N/AOct 1, 2025Cairo University
NCT07230197N/ASep 30, 2025Capital Medical University
NCT07196657N/ASep 30, 2025Capital Medical University, Central South University, Harbin Medical University, Nanchang University, Peking University, Xiamen University, Yanbian University
NCT06614322Phase 2Sep 30, 2025Harvard University, University of Rochester
NCT07186751N/ASep 20, 2025Anhui Medical University, Capital Medical University, Guangxi Medical University, Nanchang University, Peking University, Shandong University, Xinjiang Medical University
NCT07171320N/ASep 15, 2025Capital Medical University, Jiujiang University
NCT07230171N/ASep 15, 2025Capital Medical University
NCT07157852N/ASep 5, 2025Capital Medical University, China Three Gorges University, Yichang, China, Nanchang University, Peking University
NCT07063082N/AJul 7, 2025Cairo University
NCT06975345N/AJul 2, 2025Universitat Internacional de Catalunya, University of Zaragoza, Wroclaw University of Health and Sport Sciences
NCT06990854N/AJul 1, 2025Hangzhou Third Hospital, Zhejiang Chinese Medical University
NCT07029854N/AJun 18, 2025Cairo University
NCT06991153N/AMay 29, 2025Cairo University
NCT06766916Phase 2May 7, 2025Sun Yat-Sen University
NCT06861387N/AMay 1, 2025St. Antonius Hospital, Nieuwegein
NCT06969417N/AApr 10, 2025CMH Kharian Medical College
Showing 20 of 531 trials
Page 1 / 27

Organizations

Research & Development (345)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit15412451997
Cairo UniversityAcademic/Hospital242152017
Capital Medical UniversityAcademic/Hospital141432016
Seoul National UniversityAcademic/Hospital8532011
Yuhan Pharmaceutical CompanyFor profit8832011
Assiut UniversityAcademic/Hospital7742014
GL Pharm Tech CorporationFor profit7712012
Peking UniversityAcademic/Hospital7122016
Tel Aviv UniversityAcademic/Hospital7732011
Yonsei UniversityAcademic/Hospital7532009
Catholic University of KoreaAcademic/Hospital6432012
Daiichi SankyoFor profit6622011
Mayo ClinicAcademic/Hospital6442008
McMaster UniversityAcademic/Hospital6232007
Tanta UniversityAcademic/Hospital6622017
University of TorontoAcademic/Hospital6632008
Mansoura UniversityAcademic/Hospital5532011
Technion UniversityAcademic/Hospital5412008
University of LondonAcademic/Hospital5232007
University of ThessalyAcademic/Hospital5322009
345 organizations
Page 1 / 18

Marketing (64)

OrganizationOrg typeRelationshipDate
ACI LimitedFor profitMKTGApr 26, 2023
AbbVieFor profitMKTGJul 9, 2020
ActavisFor profitMKTGJan 10, 2014
Adaptis PharmaFor profitMKTGJul 18, 2022
AlembicFor profitMKTGDec 21, 2018
AlembicFor profitSYNJul 19, 2019
Alkem Labs LtdFor profitMKTGJan 29, 2019
Allergan PLC (2015)For profitMKTGApr 27, 2015
AlvogenFor profitMKTGApr 13, 2021
AlvogenFor profitMKTGJul 6, 2021
Amneal PharmaceuticalsFor profitMKTGJul 19, 2019
ApotexFor profitSYNApr 13, 2021
ApotexFor profitMKTGFeb 21, 2014
Aurobindo PharmaFor profitMKTGDec 27, 2018
Aurobindo PharmaFor profitSYNMar 29, 2023
CREEKWOOD PHARMSFor profitMKTGMar 23, 2020
Cadila HealthcareFor profitMKTGDec 27, 2018
CelltrionFor profitMKTGMar 20, 2020
Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd.For profitMKTGJul 15, 2021
Chartwell PharmaceuticalsFor profitMKTGMar 20, 2020
CiplaFor profitMKTGJan 10, 2020
Cp PharmaFor profitNDA2Dec 30, 2004
Dr. Reddy's LaboratoriesFor profitMKTGJul 19, 2019
ESKAYEFFor profitMKTGMar 8, 2022
Epic Pharma LlcFor profitMKTGJun 1, 2023
Hainan GeneralSanyang Pharmaceutical Co.,LtdFor profitMKTGSep 30, 2019
Healthcare Pharma LtdFor profitMKTGSep 26, 2012
Hetero Labs LtdFor profitMKTGOct 8, 2019
HikalFor profitMKTGMar 23, 2020
Invagen PharmsFor profitMKTGDec 14, 2018
LupinFor profitMKTGJun 4, 2013
MSN LaboratoriesFor profitMKTGJan 9, 2019
MSN LaboratoriesFor profitSYNJul 19, 2019
MSN LaboratoriesFor profitSYNJul 19, 2019
Macleods Pharmaceuticals, LtdFor profitMKTGMay 18, 2016
Marksans PharmaFor profitMKTGJul 18, 2022
MylanFor profitSYNMar 7, 2013
MylanFor profitMKTGSep 20, 2019
NeogenFor profitMKTGMay 18, 2016
NovartisFor profitMKTGDec 31, 2012
Novel Anti-Infective Technologies, LLCFor profitMKTGOct 23, 2014
Patrin Pharma IncFor profitMKTGFeb 18, 2022
PfizerFor profitNDADec 30, 2004
PfizerFor profitMKTGDec 30, 2004
Prinston IncFor profitMKTGDec 7, 2017
Prinston IncFor profitSYNSep 1, 2022
RenataFor profitMKTGDec 26, 2019
Rising PharmaceuticalsFor profitSYNNov 19, 2018
Rising PharmaceuticalsFor profitMKTGJul 19, 2019
Rubicon ResearchFor profitMKTGMar 22, 2022
SandozFor profitMKTGDec 31, 2012
Sciegen PharmaceticalsFor profitMKTGNov 23, 2018
Shijiazhuang Pharma Group (CSPC)For profitMKTGDec 26, 2019
ShuangchengFor profitMKTGSep 30, 2019
SinotherapeuticsFor profitMKTGJun 1, 2023
Sun PharmaceuticalsFor profitMKTGNov 29, 2019
TevaFor profitMKTGApr 27, 2015
Torrent Pharmaceuticals LimitedFor profitMKTGJan 4, 2019
UpjohnFor profitMKTGDec 30, 2004
Watson PharmaceuticalsFor profitMKTGApr 27, 2015
WockhardtFor profitMKTGSep 26, 2012
WockhardtFor profitNDA2Dec 30, 2004
Yiling Pharmaceutical Inc.For profitMKTGSep 30, 2019
Zydus Discovery DMCCFor profitMKTGAug 26, 2022